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赛诺菲以1.6亿美元收购mRNA技术以在体内重编程T细胞

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发表于 2021-4-13 02:43 |显示全部帖子
Sanofi pays $160M for mRNA tech to reprogram T cells in vivo
by Nick Paul Taylor | Apr 12, 2021 7:45am
Paul Hudson

Sanofi has paid $160 million upfront to buy a preclinical biotech that is using mRNA to reprogram immune cells inside the human body. The technology could enable patients to make their own CAR-T cells, eliminating the complex cell therapy supply chain while improving safety and dosing.

The biotech, LabCentral-based Tidal Therapeutics, has kept a low public profile since spinning out of the Fred Hutchinson Cancer Research Center but still quickly attracted attention. Mission BioCapital seeded the biotech with assists from investors including RA Capital, New Enterprise Associates and AbbVie Ventures. Now, Sanofi has given those investors an early exit.

Much of what is known about Tidal comes from papers published by Fred Hutch’s Matthias Stephan, M.D., Ph.D. In 2019, Stephan and his colleagues described the use of nanocarriers to deliver mRNA encoding for transcription factors that reprogram tumor-associated macrophages to reverse immunosuppression.

In mice, the nanocarriers delayed tumor progression, leading collaborators to outline a role for the macrophage-modifying treatment in combination therapies in populations refractory to other drugs. The collaborators identified ovarian cancer as a targeted indication.

Fred Hutch disclosed that the technology was exclusively licensed to Tidal. Stephan is a scientific founder of the biotech. Ulrik Nielsen, Ph.D., the co-founder of Merrimack, is CEO.

Last year, Stephan co-authored another paper describing the use of mRNA to cause in vivo creation of T cells expressing tumor-specific CARs or virus-specific TCRs. The study suggested the approach may be as effective as the adoptive transfer of engineered T cells while providing greater control over the pharmacokinetic properties of the therapy.

In a statement, Frank Nestle, M.D., chief scientific officer at Sanofi, said the “next generation, off-the-shelf approach has the potential to bring CAR-T cell therapy to a much broader patient population.”

Other biotechs see bispecific antibodies as a way to deliver CAR-T-level efficacy without taking on the complexity, costs and risks of cell therapies. However, Stephan and his collaborators said the need to give bispecifics by continuous infusion can cause systemic toxicities. The researchers also identified the ability of their system to “generate de novo tumor-specific T cells, which as a ‘living drug actively localize to the target, increase in number and serially destroy cancer cells” as an advantage.

The technology has applications in infectious diseases as well—the Fred Hutch team has engineered T cells to recognize hepatitis B—inflammatory diseases and other therapeutic areas. Sanofi valued the big, broad potential of the platform at $160 million upfront and up to $310 million in milestones.

If the technology lives up to its potential, it could give Sanofi products that generate sales that dwarf the outlay on Tidal, but the novel, early-stage nature of the approach means there are pitfalls. The Fred Hutch team identified the nanoparticles as a source of risk in the 2020 paper, explaining that “minor variations in many parameters” can affect safety and efficacy and that “only a few facilities with the requisite degree of expertise are currently operational in the United States.”

Rank: 8Rank: 8

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发表于 2021-4-13 02:43 |显示全部帖子
赛诺菲以1.6亿美元收购mRNA技术以在体内重编程T细胞
尼克·保罗·泰勒(Nick Paul Taylor)| 2021年4月12日,上午7:45
保罗·哈德森

赛诺菲已经支付了1.6亿美元的预付款,以购买临床前生物技术,该技术利用mRNA重新编程人体中的免疫细胞。该技术可以使患者制作自己的CAR-T细胞,消除复杂的细胞疗法供应链,同时提高安全性和剂量。

自从弗雷德·哈钦森癌症研究中心分离出来以来,这家基于LabCentral的生物技术公司Tidal Therapeutics一直保持低调的公众知名度,但仍迅速引起关注。 Mission BioCapital在RA Capital,New Enterprise Associates和AbbVie Ventures等投资者的协助下为该生物技术注入了种子。现在,赛诺菲已为这些投资者提供了提前退出的机会。

关于潮汐的大部分信息来自Fred Hutch的Matthias Stephan,M.D.,Ph.D.发表的论文。在2019年,斯蒂芬(Stephan)和他的同事描述了使用纳米载体来提供编码转录因子的mRNA,该转录因子可重新编程与肿瘤相关的巨噬细胞以逆转免疫抑制。

在小鼠中,纳米载体延迟了肿瘤的进展,导致合作者概述了巨噬细胞修饰疗法在难于其他药物的人群中的联合疗法中的作用。合作者确定卵巢癌为目标适应症。

弗雷德·哈奇(Fred Hutch)透露,该技术是Tidal的独家许可。斯蒂芬(Stephan)是生物技术的科学创始人。 Merrimack的联合创始人Ulrik Nielsen博士是首席执行官。

去年,斯蒂芬(Stephan)与他人合着了另一篇论文,描述了使用mRNA引起体内表达肿瘤特异性CAR或病毒特异性TCR的T细胞的产生。研究表明,该方法可能与工程化T细胞的过继转移一样有效,同时可以更好地控制该疗法的药代动力学特性。

赛诺菲(Sanofi)首席科学官弗兰克·雀巢(Frank Nestle)在一份声明中说:“下一代现成的方法有可能将CAR-T细胞疗法带给更广泛的患者群体。”

其他生物技术公司将双特异性抗体视为在不承担细胞疗法的复杂性,成本和风险的情况下提供CAR-T级功效的一种方法。但是,斯蒂芬和他的合作者说,需要通过持续输注给予双特异性药物可能会引起全身毒性。研究人员还确定了其系统“产生从头开始的肿瘤特异性T细胞的能力”,这是一种优势,它是一种“活跃地定位在靶标上的活体药物,数量增加并连续破坏癌细胞”。

该技术也适用于传染病-弗雷德·哈奇(Fred Hutch)团队设计了T细胞以识别乙型肝炎-炎性疾病和其他治疗领域。赛诺菲对平台的巨大潜力进行了评估,其预付款额为1.6亿美元,里程碑金额最高为3.1亿美元。

如果这项技术能够发挥其潜力,它可以为赛诺菲提供能产生一定销售量的产品,从而使Tidal的支出相形见,,但是这种方法的新颖,早期性质意味着存在陷阱。弗雷德·哈奇(Fred Hutch)团队在2020年的论文中将纳米颗粒确定为风险来源,并解释说“许多参数的微小变化”会影响安全性和功效,并且“目前只有少数具有必要专业知识水平的设施在美国运营”。状态。”
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